A study of antipsychotic response and cognition using TMS-EEG V1
Overview
Participants wanted for brain stimulation –EEG study
A novel TMS-EEG study of GABAergic and glutamatergic neurotransmission and cognitive control in antipsychotic treatment response in schizophrenia
Researchers at the Institute of Psychiatry, Psychology and Neuroscience, King’s College London are seeking healthy volunteers aged 18 – 55 for a Transcranial Magnetic Stimulation (TMS) – Electroencephalography (EEG) study.
We would like to invite you to take part as a healthy control participant in a research study relating to the brain response to antipsychotics in people diagnosed with schizophrenia or schizoaffective disorder.
We will use a brain stimulation technique called Transcranial Magnetic Stimulation (TMS) to activate the brain and we will record the brain activity using electroencephalography (EEG). Both TMS and EEG are normally completely safe and have been used for many years. We will also ask you to complete some tests of thinking abilities. You will not be asked to take any medications during the study.
This study involves three visits to the NIHR/Wellcome King’s Clinical Research Facility (CRF) at King’s College Hospital. Each visit will take no more than 2 and 45 minutes.
Volunteers will be reimbursed for their time.
Recruitment for the study will close at the end of September 2024.
Thank you for your time!
Are you interested in taking part in this study?
Planned end date
30 Jun 2025 00:00Conditions
SchizophreniaInclusion Criteria
Inclusion criteria for participants with schizophrenia
SCZ or Schizoaffective Disorder diagnosis as per DSM-5
Males or females
Aged between 18-55
Right-handed, as per Edinburgh Handedness Inventory
Outpatient with no hospitalisation for worsening of SCZ/Schizoaffective disorder within at least 3 months prior to screening visit
Stable on current AP treatment for at least 3 months prior to screening visit and adherent with AP treatment, as per self-report and medical notes
AP monotherapy with either olanzapine, aripiprazole, risperidone or paliperidone for both responder and non-responder groups
Non-responders will have: i) a score of at least 4 (moderate) on at least two positive symptom items of the Positive and Negative Syndrome Scale (PANSS) and ii) at least two prior AP trials of at least 4-6 weeks duration with inadequate clinical improvement [41]
Responders will have a score of 3 or less on all items of the PANSS
Score≤20 in Beck Depression Inventory (BDI)
Physically healthy based on medical history as per interview at screening visit and medical notes
Negative urine pregnancy test at screening visit
Capacity to give written informed consent
Inclusion criteria for healthy controls
Males or females
Aged between 18-55
No personal or family history of psychotic disorder
Right-handed as per Edinburgh Handedness Inventory
Score≤20 in Beck Depression Inventory (BDI)
Physically healthy as per interview at screening visit
Negative urine pregnancy test at screening visit
Capacity to give written informed consent
Exclusion Criteria
Exclusion criteria for participants with schizophrenia
Diagnosis of alcohol or substance dependence (other than nicotine) in the last 6 months preceding the screening visit as per Mini International Neuropsychiatric Interview (MINI) and the participant’s medical notes
Current treatment with Clozapine or unsuccessful trial with Clozapine in the last 3 months prior to screening visit
Treatment with CNS active medications (other than APs) that may affect performance on the study-related tasks, such as benzodiazepines, sleep medications or stimulants in the last 3 months prior to screening visit
Electroconvulsive therapy (ECT) in the last 6 months prior to the screening visit
Severe/uncontrolled/unstable physical illnesses that may affect participation in the study or pose a risk to the participant’s safety such as, uncontrolled diabetes, asthma, hypertension, cardiac-related problems including syncopal episodes
Systematic neurological disorder, including stroke, significant traumatic brain injury, epilepsy, multiple sclerosis, Parkinson's disease
No significant side effects from the AP treatment, as measured by Glasgow Antipsychotic Side Effects Scale (GASS) score of ≤21
Significant head or spinal cord injury
Diagnosis of migraine
Pregnancy or lactation
Exclusion criteria for healthy controls
• Diagnosis of alcohol or substance dependence (other than nicotine) in the last 6 months preceding the screening visit as per Mini International Neuropsychiatric Interview (MINI) and the participant’s medical notes
• Treatment with CNS active medications that may affect performance on the study-related tasks, such as benzodiazepines, sleep medications or stimulants in the last 3 months prior to screening visit
• Severe/uncontrolled/unstable physical illnesses that may affect participation in the study or pose a risk to the participant’s safety such as, uncontrolled diabetes, hypertension, cardiac-related problems including syncopal episodes
• Systematic neurological disorder including stroke, significant traumatic brain injury, epilepsy, multiple sclerosis, Parkinson's disease
• Significant head or spinal cord injury
• Diagnosis of migraine
• Pregnancy or lactation
• Unwillingness or inability to follow the protocol procedures
• Participation in research studies using brain stimulation or cognitive enhancing medications in the last 3 months prior to screening visit
• Contraindications to TMS as per TMS safety guidelines [42, 43] including:
History of epileptic seizures and/or previous or current diagnosis of epilepsy as per participant’s medical records
On medications with seizure threshold lowering potential including imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, foscarnet, ganciclovir, ritonavir, theophylline, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporin, chlorambucil, vincristine, methotrexate, cytosine arabinoside, lithium, sympathomimetics.
Presence of metallic hardware and /or implants that contain magnets on the skull/brain, such as intracranial ferromagnetic metal implants, cochlear implants, or medications pumps, implanted neurostimulators, such as Deep Brain Stimulators
Cardiac pacemaker or intracardiac lines
Presence of metal in the body
For all participants, on occasions where it is not possible for the protocol to be followed, e.g. due to communication barriers, participants will not be consented into the study.